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Supplements are the Wild West of health. One Attorney General is out to change that.

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Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.

When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Wikipedia vs Quackery – Standards vs Chaos

Wikipediasmall

Wikipedia’s front page

Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.

Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.

Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.

This is all meant to ensure that individual patients receive the highest quality of care.

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Posted in: Politics and Regulation, Science and Medicine

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How should the FDA regulate homeopathic remedies?

Hyland's "4 Kids Complete Allergy" homeopathic preparation (not for use with food allergies)

Hyland’s “4 Kids Complete Allergy” homeopathic preparation (not for use with food allergies), one of many unregulated, unproven over-the-counter preparations sold in the United States

The FDA announced recently that it is holding a public hearing on April 21 and 22,

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

It’s about time. We know that homeopathic remedies are not, and cannot be, effective. I will not plough that ground again here. Unfortunately, the FDA does not have any authority to bar these fraudulent products from sale altogether. Only Congress can do that.

In this post, I review the current regulatory framework for homeopathic products. I then explore the possibilities, given the opportunities for regulatory change presented by the FDA at this time. In doing so, I answer some of the questions posed by the FDA in its formal notice of the hearing, printed in the Federal Register.

I argue that the FDA has no statutory authority for the manner in which it currently regulates (or, actually, doesn’t regulate) homeopathic drugs. I further argue this system, largely controlled by the homeopathic industry, must be abandoned, and that there is no reason why homeopathic drugs should not be regulated just like any other OTC or prescription drug.

(Note to those wanting to submit written comments or attend the hearing: there are deadlines and other requirements for participation. You can read those in the Federal Register.)
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Posted in: Clinical Trials, Homeopathy, Legal, Politics and Regulation

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Should the FDA crack down on homeopathic “remedies”?

In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a complementary or alternative product that could cause serious harm, this is it:

oral-asthma-spray

Photo Credit Ryan Meylon

 

Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following: (more…)

Posted in: Homeopathy, Politics and Regulation

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Lyme: Two Worlds Compared and Contrasted

The Lyme tick

The western black-legged tick, carrier of the Borrelia burgdorferi bacteria which causes Lyme disease.

The practice of infectious disease (ID) is both easy and difficult. If you read my ID blog on Medscape you are aware of my trials and tribulations in diagnosing and treating infections.

ID is easy since, at least in theory, diseases have patterns and an infecting organism has a predictable epidemiology and life cycle. So if you can recognize the pattern and relate it to the life cycle and exposure history, you can often make a diagnosis before the cultures come back.

My favorite story is the time I was asked to see a young girl with endocarditis. The history was she had a week of fevers, headache and myalgia that went away for five days, returned for a week, went away for five days and returned yet again.

So I asked her “How was your vacation at Black Butte?”

The look of astonishment on her face as she asked how I knew she had been to Black Butte was so satisfying. (more…)

Posted in: Legal, Naturopathy, Politics and Regulation, Public Health, Science and Medicine

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The DC as PCP? Drug Wars Resume

Coming soon, to a chiropractor's office near you?

Coming soon, to a chiropractor’s office near you?

Chiropractors are once again engaged in intra-fraternal warfare over the chiropractic scope of practice, a saga we’ve chronicled before on SBM. (See the references at end of this post.) Every time it looks like the warring factions have buried their differences, they come rising to the surface like zombies.

The International Chiropractors Association (ICA), representing the “straight” faction, wants chiropractic to continue as a drugless profession. They are happy to detect and correct subluxations, thereby removing “nerve interference” and “allowing the body to heal itself” in the tradition of Daniel David Palmer. But the American Chiropractic Association (ACA) has bigger fish to fry.

This time, the ICA is upset that the ACA House of Delegates up and decided to establish a “College of Pharmacology and Toxicology,” which would operate under the auspices of the ACA Council on Diagnosis and Internal Disorders. The ACA’s announcement of the “College” is rather vague on details:

The purpose of the College is to further educate the chiropractic profession on clinical matters related to the widespread use of both prescription and over-the-counter medications and nutritional supplements.

I e-mailed the ACA several days ago asking for more information but have yet to receive a reply.

The ICA sees this move as yet another attempt by:

forces at work within some organizations actively promoting incorporating drugs into the chiropractic scope of practice.

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Posted in: Chiropractic, Herbs & Supplements, Humor, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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A brief bit of shameless self-promotion…The Prince of Wales edition

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In an effort to expand the Gorski empire almost to the level of the Crislip empire and to try to make it to somewhere within two or three orders of magnitude of the Novella empire, I’ve published an article on Slate.com about Prince Charles’ visit to our fine country entitled “Prince of Pseudoscience“. Consider this the mandatory shameless self-promotion that all SBM bloggers take advantage of from time to time to publicize their activities elsewhere.

Enjoy! (I hope.)

I’m told that Dana Ullman has made an appearance in the comments. I might have to head on over after work tonight…

Posted in: Announcements, Homeopathy, Politics and Regulation, Science and the Media

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ND Confession, Part 1: Clinical training inside and out

Editors’ note: With this guest post, we welcome Britt Marie Hermes to the SBM blog. Her new blog NaturopathicDiaries.com was mentioned by Jann Bellamy last week. Hermes is a former naturopath who came to doubt naturopathy. Through her contact with Jann, she has agreed to contribute occasional blog posts to us. Her insights into the pseudoscientific medical system of naturopathy, her reasons for becoming a naturopath, her reasons for leaving naturopathy, and, most importantly, her inside knowledge of naturopathy, will provide compelling reading. See also ND Confession, Part II: The Accreditation of Naturopathic “Medical” Education.


In 2011, I graduated from Bastyr University with a doctorate in naturopathic medicine. I passed the Naturopathic Physicians Licensing Examination (NPLEX) and landed a competitive, one-year residency in family medicine and pediatrics at an out-patient clinic in Seattle. When I completed my residency, I remained at this clinic for a brief time before moving to Arizona to practice until 2014.

During my time in Arizona, I realized that my profession had severely misled me. Naturopathic medicine is marketed as a “distinct form of primary health care.” This phrase is ubiquitous: it appears on the websites of naturopathic medical schools, on materials published by practicing naturopaths, and on lobbying documents to promote the unfettered licensure of naturopaths and to expand eligibility for federal loan repayment programs. Based on my educational and professional experience as an accomplished member of the naturopathic community, I can say that naturopathic medicine might be a distinct form of something, but it is not any form of primary health care. I am saddened to report that not only was I misled, but so were hundreds of legislators, thousands of students, and tens of thousands of patients.

Patient undergoing hydrotherapy treatment

Historical image of a patient undergoing hydrotherapy treatment. Image from the History of Medicine (NLM).

Given my journey through naturopathic medical school, I can provide strong evidence and testimony of the quality and quantity of training at Bastyr University. I base what follows on my academic transcript, course syllabi, course catalog, and the student clinician’s handbook in addition to my personal experiences. It should come as no surprise to readers of ScienceBasedMedicine.org that naturopathic training is not as the profession presents. I’ll say it anyway: naturopathic education is riddled with pseudoscience, debunked medical theories, and experimental medical practices.

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Posted in: Naturopathy, Politics and Regulation

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Florida tells Brian Clement to stop practicing medicine

This is a screenshot from the website of the Hippocrates Health Institute, showing its grounds.

Screenshot of the Hippocrates Health Institute’s website

 
Note: Also posted today is a brief profile of a new blog, Naturopathic Diaries: Confessions of a Former Naturopath, by Britt Marie Deegan Hermes, a trained naturopath who became disillusioned with her profession. I encourage you to have a look!

The State of Florida has finally taken action against Brian Clement.

David Gorski, Orac, and the Canadian media, especially the Canadian Broadcasting Corporation (CBC), have done an excellent job of chronicling the activities of “Dr.” Clement. All have reported on Florida’s taking action against Clement. I’ll give a brief background here, most of which comes from Dr. Gorski’s most recent post, as well as add some information and observations to theirs.

Hippocrates Health Institute, located in West Palm Beach, Florida, is licensed as a massage establishment by the state and run by Brian Clement and his wife, Anna Maria Gahns-Clement. Clement and Hippocrates came to the attention of the Canadian media when, last year, the families of two Canadian aboriginal girls withdrew their children from conventional cancer treatment, including chemotherapy. Prior to that, Clement had basked in the glory of fawning reports from local media, one of which described him as having an “inimitable, engaging style.” Another described him as coming “fresh from a detoxifying sauna” to the interview.

Had they completed conventional treatment, both girls had a very good chance of survival. The families opted instead for traditional medicine as well as “alternative medicine” at Hippocrates. Each paid a reported $18,000 for participation in a “Life Transformation Program” there. This included, for at least one of the girls, cold laser therapy, vitamin C injections and a strict raw vegetable diet.

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Posted in: Cancer, Health Fraud, Legal, Naturopathy, Nutrition, Politics and Regulation

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What do we do about politicians and physicians who promote antivaccine misinformation?

Given the ongoing (and increasing) measles outbreak linked initially to Disneyland, it’s hard for me not to revisit the topic from time to time. This time around, there are two issues I wish to discuss, one political and one that is a combination of medical and political. After all, it was just one week ago when New Jersey Governor Chris Christie stepped in it by advocating parental choice in vaccines, as if parents don’t already have a choice. He rapidly had to walk it back, and his ill-considered remarks were almost certainly not evidence that he is antivaccine. They are, however, evidence that he doesn’t understand that we do not have “forced vaccination” in this country (we have school vaccine mandates). Parents already have choice in 48 states, given that only two states (Mississippi and West Virginia) do not allow belief-based non-medical exemptions, be they religious exemptions, personal belief-exemptions, or both, to school vaccine mandates. It also came out that in 2009 while running for Governor, Christie met with Louise Kuo Habakus (who is antivaccine) and the NJ Coalition for Vaccine Choice, a very vocal NJ antivaccine coalition whose member organization list reads like a who’s who of the national antivaccine movement and includes Life Health Choices, the antivaccine organization founded by Habakus. He even wrote a letter promising that as governor he would stand with them in “their fight for greater parental involvement in vaccination decisions that affect their children.”

It’s also evidence that vaccine mandates are becoming even more politicized. Indeed, Senator Rand Paul, on the very same day, provided more such evidence when he claimed on a conservative talk radio show that he’s seen children with severe neurological problems after vaccination, the implication being that he believed these children’s problems were linked to vaccination. Later, in a testy exchange with a CNBC reporter, who asked him whether he had really said that he thought vaccines should be voluntary, Paul sarcastically replied, “I guess being for freedom would be unusual.” Later in the exchange, after repeating the same antivaccine talking points that he had related earlier in the day, he said, “The state doesn’t own the children. Parents own the children, and it is an issue of freedom.” You get the idea. He, too, ultimately had to back off a bit, famously showing himself getting vaccinated for hepatitis A, but given that Paul has had a long history of making similar comments, this was almost certainly strategic.
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Posted in: Politics and Regulation, Public Health, Religion, Vaccines

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